BUFFALO, N.Y. The first controlled clinical trial to test the safety and efficacy of interventional endovascular therapy on the symptoms and progression of multiple sclerosis has found that the intervention, sometimes called the "liberation treatment," which has attracted intense interest in the global MS community, does not improve patient outcomes. In a few cases, the treatment made symptoms worse.
University at Buffalo researchers will present their results in an "Emerging Science" poster session March 20 at the annual American Academy of Neurology meeting in San Diego. They discuss the findings in this video (http://youtu.be/94gLM4QlU_A).
The Prospective Randomized Endovascular Therapy in MS (PREMiSe) trial is believed to be the first prospective randomized double-blinded, controlled study of balloon angioplasty for MS being performed with Institutional Review Board approval in a rigorous fashion in the U.S. with significant safeguards in place to ensure careful determination of risks and benefits. All screening, diagnostic, interventional and follow-up procedures and visits were performed at no cost to the patients.
The study's key findings are that while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients.
Based on their findings, the UB researchers' primary message to MS patients and their doctors is that endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI) should only be done in the context of randomized, double-blinded, controlled studies like PREMiSe.
"Our strong recommendation to patients and to practitioners, who have, in earnest, been seeking betterment for their disease and a cure for MS is that they should instead consider enrolling in trials, rather than undergoing these procedures on a fee-for-service basis," said Adnan Siddiqui, MD, as
|Contact: Ellen Goldbaum|
University at Buffalo